Kornimate/medical-research-clean huggingface dataset:
interscalene catheter vs. interscalene liposomal bupivacaine for arthroscopic rotator cuff repair

Conditions: Pain, Postoperative

Summary: arthroscopic rotator cuff repair often causes significant postoperative pain. an interscalene nerve catheter is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of shoulder surgery. liposomal bupivacaine (exparel) was recently approved by the fda for use around the interscalene brachial plexus, and it has been shown to be an effective option, but its analgesic efficacy has limited data. both techniques are currently being used at the unc's ambulatory surgery center (asc) for analgesia after shoulder arthroscopy. the goal is to ensure that the fairly new exparel option provides non-inferior analgesia as compared to the prior standard practice of placing a nerve catheter with plain bupivacaine. the investigators hope to ensure the quality of pain control around the time of shoulder arthroscopy at this institution by prospectively and rigorously collecting data during regular follow up.

this is a prospective comparison of patients undergoing rotator cuff repair that receive one of two types of interscalene nerve block, both of which are currently being used at unc. group 1 will be comprised of patients with a preoperative interscalene nerve catheter placed with 20 ml 0.25% bupivacaine and a 0.2% ropivacaine infusion by an onq pain pump. group 2 will be comprised of patients with a preoperative interscalene nerve block placed with 10 ml 0.5% bupivacaine and 10 ml 1.3% liposomal bupivacaine (exparel). all patients in both groups will have a similar intraoperative general anesthetic with multimodal analgesic pre-op oral medications.

Eligibility criteria:
inclusion criteria: * adult patients age \> 18 undergoing arthroscopic rotator cuff repair at the ambulatory surgery center at the university of north carolina exclusion criteria: the below are simply contraindications to regional anesthesia in general, this is a pragmatic study to evaluate the quality of care for these patients with no additional exclusion criteria. * contraindications to regional anesthesia * significant peripheral neuropathy or neurological disorder affecting the upper extremity * pregnancy * cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
six months clinical and echocardiographic outcome of arni lcz696 therapy in hfref patients

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: to evaluate the clinical and echocardiographic outcome of lcz696 therapy in hfref (nyha class ii - iv and ef =≤ 40%).patients, in addition to the efficacy of lcz696 in reducing mortality and rehospitalisation rate.


Eligibility criteria:
inclusion criteria: 1. ≥18 year old. 2. functional class using new york heart association (nyha) classification class ii, iii or iv %). 3. left ventricular systolic dysfunction using transthoracic echocardiography with ef ≤ 40%. 4. who was already taking ace inhibitors or arbs. exclusion criteria: 1. symptomatic hypotension. 2. systolic blood pressure \<100 mm hg. 3. estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2. 4. history of angioedema. 5. hisotry of unacceptable side effects while on while on treatment with an ace-inhibitor or arbs.
treatment targets in spanish and english bilingual speech intervention

Conditions: Speech Sound Disorder

Summary: the goal of this clinical trial is to learn which speech treatment targets result in the greatest amount of speech learning in spanish-english bilingual children with speech sound disorders. the main questions it aims to answer are: * does linguistic complexity of the treatment target increase the amount of generalized learning within the treated language? * does linguistic complexity of the treatment target increase the amount of generalized speech across languages? researchers will compare intervention effects across treatment provided in english and spanish to see if the effect differs according to the language of intervention. participants will: * attend between 12 and 18 45-minute speech intervention sessions in spanish or english for up to 6 weeks * attend assessment visits before and after intervention * attend follow-up assessment visits 1 month and 2 months after intervention

this study is a single-subject experimental design with staggered multiple baselines examining speech intervention for spanish-english bilingual children with speech sound disorders. the study includes two arms based on the language of intervention (spanish or english). within each arm are two conditions that manipulate the linguistic complexity of the speech treatment target (simple consonant singleton or complex consonant cluster). participants will be pseudo-randomly assigned to these arms and conditions. the primary outcome is system-wide generalization; specifically, a) within-language and b) across-language generalization to untreated sounds. accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech probes in english and spanish. the entire generalization probe is administered at each assessment visit (pre, post, and 1- and 2-month follow-ups), and shorter subset probes targeting only monitored sounds are administered during baselines and weekly during treatment.

Eligibility criteria:
inclusion criteria: * participants will be regularly exposed to english for at least 3 months in one of the following ways: a) an english-speaking caregiver or sibling who interacts with the child on a daily basis in english, b) attendance at an english-speaking daycare, preschool, or elementary school. * caregivers will have reported concern with their child's speech development and/or reduced intelligibility on the intelligibility in context scale in spanish or english. * participants will present with 5 or more consonants or clusters missing from their phonetic inventories in each language to confirm presence of a speech sound disorder and sufficient gaps in phonological knowledge to warrant treatment. exclusion criteria: * participants receiving speech or language treatment elsewhere during their participation in this project.

Keywords: speech speech sound disorder bilingual treatment targets
rct to evaluate the efficacy and safety of ivy leaves cough liquid vs. placebo in the treatment of acute cough

Conditions: Acute Cough

Summary: randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough


Eligibility criteria:
inclusion criteria: 1. acute cough with symptoms lasting 2-3 days prior to treatment 2. men or women of any ethnic origin 3. age 18 to 75 years 4. subjects who are able to understand and are willing to comply to trial instructions 5. having given written informed consent 6. satisfactory health except for the cough as determined by the investigator based on medical history and physical examination 7. cs score of at least 50 mm on a 100 mm vas at v1 8. acute bss of at least 10 points at v1 9. vcd score of at least 2 points at v1 exclusion criteria: 1. allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease 2. history of hypersensitivity to any excipient of the applied drugs 3. history of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever 4. history of chronic gastritis or peptic ulcers 5. any gastrointestinal complaints within 7 days before v1 6. participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly 7. treatment with corticoids, beta-2 agonists (e.g. salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, angiotensin-converting enzyme (ace) inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate or homeopathic drugs against common cold within 7 days before v1 8. drug or alcohol abuse in the opinion of the investigator 9. pregnant or nursing (lactating) women 10. women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception. 11. subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject's ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease. 12. subjects directly or indirectly involved in the execution of this protocol, including employees of the cro and persons related to them.
shoulder and neck mobilization in patients with subacromial impingement syndrome

Conditions: Subacromial Impingement Syndrome

Summary: patients who come to tavşanlı state hospital's physical therapy and rehabilitation department and have been diagnosed with subacromial impingement syndrome by a physician will be included. patients will be selected by randomization method among the patients determined by the physician to receive conservative treatment, shoulder mobilization in addition to conservative treatment, and neck mobilization treatment program in addition to these. conventional treatments such as hot packs, tens, ultrasound, and exercise will be given to all patients by the hospital staff. pain intensity will be evaluated with vas. additionally, painful arch and pain-free joint range of motion evaluation will be made using a goniometer. the dash questionnaire will be used to evaluate shoulder functionality. sensory evaluation will be made with pressure pain threshold and two-point discrimination tests. measurements will be made before the intervention and repeated after 3 weeks of intervention.


Eligibility criteria:
inclusion criteria: * being over 18 years of age * diagnosed with subacromial impingement * not having received any treatment for shoulder problems in the last 6 months * the pain has been continuing for 3 months * initial pain must be 4 or higher on the visual analog scale (vas) exclusion criteria: * history of surgery in the shoulder, cervical and thoracic region * having a shoulder problem such as a frozen shoulder or instability * full-thickness rotator cuff tear * having systemic musculoskeletal disease * having systemic rheumatic disease * history of upper extremity fracture * diagnosed with scoliosis * have neurological problems
efficacy of a multi-level school intervention for lgbtq youth

Conditions: Depression; Anxiety; Post Traumatic Stress Disorder; Coping Behavior; Sexual Minority Stress; Suicidality; Substance Use; Bullying; Harassment

Summary: efficacy of a multi-level school intervention for lgbtq youth

the goal of this r01 grant is to test the efficacy of a theoretically informed, lgbtq-affirming intervention (proud \& empowered; p\&e) alongside a school climate intervention (make space). sexual and gender minority adolescents (sgma) experience victimization in schools at much higher rates than their peers, and although sgma experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce. the investigators p\&e intervention aims to allow youth participants to discuss their experiences of bullying and victimization, to build coping skills and to plan stress management strategies, while the investigators make space intervention is an indirect, environmental strategy aimed at improving overall school climate. the investigators goal will be achieved by completing three specific aims: 1) determine participant-level efficacy of the intervention in an rct with 24 schools (6-10 schools each year over 4 years); 2) determine the school-wide intervention effects on (a) reporting of minority stress and behavioral health outcomes among all sgma students and (b) perceptions of school climate (norms, attitudes, beliefs, bullying behaviors toward sgm youth, policies) among all students, and; 3) examine factors that may affect intervention success (e.g., fidelity of implementation, barriers or facilitators to implementation, school or student characteristics) to prepare the intervention for future dissemination. this intervention has been tested in a previous, smaller, feasibility study with 4 high schools.

Eligibility criteria:
inclusion criteria: * lgbtq student in one of 24 high schools exclusion criteria: * not meeting inclusion criteria

Keywords: lgbtq+ youth lgbt youth queer youth
caffeine consumption and mortality in diabetes

Conditions: Diabetes Mellitus

Summary: previous studies suggested an inverse relationship between coffee consumption and mortality in the general population. furthermore, an inverse association between coffee consumption and serum biomarkers of inflammation and insulin resistance has been described. prospective studies showed that coffee consumption might be associated with reduction in the incidence of type 2 diabetes. although caffeine consumption appears to be associated with a decreased risk of developing type 2 diabetes, the relationship between caffeine consumption and mortality in patients with diabetes remains uncertain. the current analysis aimed to assess the effects of caffeine consumption and caffeine source on all-cause, cardiovascular and cancer mortality among patients with diabetes.


Eligibility criteria:
inclusion criteria: * nhanes participants from 1999 to 2010 above 18-year old, with diagnosis of diabetes exclusion criteria: * implausible alimentary reports (defined as consumption of less than 500 kcal/day or more than 3500 kcal/day) * missing information on caffeine consumption * missing information on mortality
correlation between the analysis of the rapid cortical oscillations, the general movements of the preterm's and the cerebral palsy

Conditions: Cerebral Palsy

Summary: the general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.

compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.

Eligibility criteria:
inclusion criteria: * children been born between 15/01/08 and 15/01/10 * children whose term is lower than 28 weeks of amenorrhoea exclusion criteria: * born child superior to 28 weeks of amenorrhoea * presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative
a clinical study to assess the effect of clopidogrel on the pharmacokinetics of selexipag and its active metabolite in healthy male subjects

Conditions: Healthy Subjects

Summary: the purpose of this study is to evaluate the effect of clopidogrel on the pharmacokinetics of selexipag and its active metabolite (act-333679) in healthy male adults (by determining the blood concentrations of selexipag and its metabolite). also, the safety of selexipag when administered alone or with clopidogrel will be assessed.


Eligibility criteria:
inclusion criteria: * signed informed consent in the local language prior to any study-mandated procedure. * healty male subjects aged between 18 and 45 years (inclusive) at screening. * body mass index from 18.0 to 28.0 kg/m2 (inclusive) at screening. * systolic blood pressure (sbp) 100-145 mmhg, diastolic blood pressure (dbp) 50-90 mmhg, and pulse rate 45-90 bpm (inclusive). exclusion criteria: * any contraindication included in the smpc of selexipag or clopidogrel treatment. * history or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatments. * history or clinical evidence of any disorder of hemostasis, hemorrhagic diathesis, nose or gingival bleeding, hemophilia, thrombotic thrombocytopenic purpura, presence of any lesions with a propensity to bleed (particularly gastrointestinal and intraocular), history of bleeding complications after surgical procedures such as tooth extraction * previous history of stroke, fainting, collapse, syncope, orthostatic hypotension,vasovagal reactions, head injury. * excessive caffeine consumption * nicotine consumption within 3 months prior to screening, and inability to refrain from nicotine consumption during the course of the study * previous treatment with any prescribed medications (including vaccines) or over the counter (otc) medications (including herbal medicines such as st john's wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first selexipag administration. * subjects with rare hereditary problems of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. * any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Keywords: selexipag clopidogrel
synchronized cardiac assist for cardiogenic shock

Conditions: Shock, Cardiogenic; High Risk Percutaneous Coronary Interventions

Summary: the purpose of this study is to collect prospective safety and performance information for the i-cor® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.


Eligibility criteria:
inclusion criteria: patients in cardiogenic shock in the setting of acute myocardial infarction or patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab. cardiogenic shock is defined as * systolic blood pressure \< 90 mmhg for at least 30 min or * inotropes are needed to maintain blood pressure \> 90 mmhg or * clinical signs of heart insufficiency with pulmonary congestion or * signs of end organ hypoperfusion with at least one of the following criteria: * altered mental status * cold, damp skin or extremities * oliguria (≤ 30 ml/h) * serum lactate \> 2.0 mmol/l written consent of the patient or the legal caregiver - exclusion criteria: * age \> 85 years * cardiac arrest out of hospital with return of spontaneous circulation (rosc) \> 10 min * coma with fixed pupils not induced by drugs; * mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture) * non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.) * fever (body temperature \> 38.0 °c) or other evidence of sepsis * onset of cardiogenic shock \> 6 h before enrollment; * lactate \> 22 mmol/l; * massive pulmonary embolism; * severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters * previous known aortic regurgitation greater than grade ii * contra-indications for anticoagulation * severe hemolysis of any cause * patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
active living after cancer: implementation within be well acres homes

Conditions: Cancer; Fatigue

Summary: the goal of this research study is to learn more about a physical activity program adapted for cancer survivors.

primary objectives: evaluate the effectiveness of alac adapted for delivery in acres homes, using a randomized wait- list-control group design. the primary outcome will be physical functioning as measured by the 30- second sit-to-stand test at 12 weeks. secondary outcomes will include physical functioning measured by the six-minute walk, objective and self-reported physical activity, social connectedness, and quality of life. the investigators will also investigate whether program effects are maintained at 6 months. hypothesis: cancer survivors in the adapted alac program will increase their physical activity and improve their physical functioning from baseline to the end-of-intervention assessment, compared to a wait-list-control group. compare the reach of the alac program in acres homes to alac in other persistent poverty neighborhoods in houston. hypothesis: the acres homes adaptation of alac will have a greater reach (percent of cancer survivors enrolling in alac in a specific neighborhood) than in other persistent poverty neighborhoods in houston. explore the moderating effects of social and environmental variables on program effectiveness. hypothesis 3a:participants' financial distress, experiences of discrimination, health literacy, and social connectedness will influence the effect of the alac intervention on participants' physical activity, physical functioning, and program engagement. hypothesis 3b: neighborhood characteristics, like walkability, crime rate, air quality, access to green space, and neighborhood social vulnerability, will be related to the effectiveness of the alac program in terms of enrollment and health outcomes.

Eligibility criteria:
inclusion criteria: 1. past diagnosis of invasive cancer, or a caregiver (family or friend) of a participating survivor. 2. no longer receiving treatment for cancer (except hormone therapy or long-term maintenance chemotherapy). 3. over the age of 18. 4. screen negative for contraindicating health problems on the adapted physical activity readiness questionnaire (par-q),79 or screened positive but have approval from a health care provider to participate. 5. lives in the acres homes neighborhood of houston, texas or has a home zip code of 77088 or 77091. 6. able to provide informed consent. exclusion criteria: 1. women who are pregnant (as indicated by self-report). 2. has participated in the alac program within the past year and attended more than 2 group sessions.